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临床试验中PCR的质量保证与应用

Quality assurance and use of PCR in clinical trials.

作者信息

Reichelderfer P S, Jackson J B

机构信息

Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892, USA.

出版信息

PCR Methods Appl. 1994 Dec;4(3):S141-9. doi: 10.1101/gr.4.3.s141.

DOI:10.1101/gr.4.3.s141
PMID:7580896
Abstract

Qualitative and quantitative HIV-1 DNA and RNA PCR assays are proving to be useful in the diagnosis of HIV-1 infection in infants and in assessing the in vivo antiviral activity of new therapies and regimens in clinical trials. The use of these standardized commercial assays in conjunction with an external quality assurance program has ensured that results from different laboratories are comparable. In addition, real-time proficiency monitoring has the potential to detect problems immediately before patient data are compromised.

摘要

定性和定量的HIV-1 DNA及RNA聚合酶链反应检测,在诊断婴儿HIV-1感染以及评估临床试验中新疗法和治疗方案的体内抗病毒活性方面,正被证明是有用的。将这些标准化的商业检测与外部质量保证计划相结合,确保了不同实验室的结果具有可比性。此外,实时能力监测有可能在患者数据受到影响之前立即发现问题。

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